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A 12-Week, Randomized, Double-Masked, Parallel Group Comparison Of Evening Dosing With Xalacom In Subjects With Glaucoma

NCT ID: NCT00159653

Last Updated: 2021-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2007-06-30

Brief Summary

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To demonstrate statistical superiority of the combination of latanoprost and timolol to the individual therapy of latanoprost and timolol based on intraocular pressure measurements at 8 AM, 10 AM, 4 PM at weeks 2, 6 and 12.

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Detailed Description

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Conditions

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Glaucoma, Open-Angle Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Xalacom

Intervention Type DRUG

Xalatan

Intervention Type DRUG

Timolol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Uni- or bilateral diagnosis of primary open angle glaucoma or ocular hypertension on beta-blocker monotherapy or dual therapy in which at least one medication is a beta-blocker for at least 4 weeks prior to screening

Exclusion Criteria

* Closed/ barely open anterior chamber angle or history of acute angle closure glaucoma.
* History of ALT (Argon Laser Trabeculoplasty) or SLT(selective Laser) within 3 months prior to screening
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Phoenix, Arizona, United States

Site Status

Pfizer Investigational Site

Poway, California, United States

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Pfizer Investigational Site

Redding, California, United States

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Redding, California, United States

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Danbury, Connecticut, United States

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Cape Coral, Florida, United States

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Lakeland, Florida, United States

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Ormond Beach, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Morrow, Georgia, United States

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Homewood, Illinois, United States

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Overland Park, Kansas, United States

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Louisville, Kentucky, United States

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Shreveport, Louisiana, United States

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North Dartmouth, Massachusetts, United States

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Saint Joseph, Michigan, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Newark, New Jersey, United States

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Bethpage, New York, United States

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New York, New York, United States

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Charlotte, North Carolina, United States

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Charlotte, North Carolina, United States

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High Point, North Carolina, United States

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Matthews, North Carolina, United States

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Wilmington, North Carolina, United States

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Tulsa, Oklahoma, United States

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Cranberry Township, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Mt. Pleasant, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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North Charleston, South Carolina, United States

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Memphis, Tennessee, United States

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Amarillo, Texas, United States

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Houston, Texas, United States

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Calgary, Alberta, Canada

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Nanaimo, British Columbia, Canada

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Moncton, New Brunswick, Canada

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Saint John, New Brunswick, Canada

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Saint John, New Brunswick, Canada

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Bridgewater, Nova Scotia, Canada

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Barrie, Ontario, Canada

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Markham, Ontario, Canada

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Mississauga, Ontario, Canada

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Oakville, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Pfizer Investigational Site

Saskatoon, Saskatchewan, Canada

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Pfizer Investigational Site

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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United States Canada

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6641027&StudyName=A%2012-Week%2C%20Randomized%2C%20Double-Masked%2C%20Parallel%20Group%20Comparison%20Of%20Evening%20Dosing%20With%20Xalacom%20In%20Subjects%20With%20Glaucoma

To obtain contact information for a study center near you, click here.

Other Identifiers

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A6641027

Identifier Type: -

Identifier Source: org_study_id

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